September 28, 2025，Simcere Zaiming, an innovative oncology-focused subsidiary of Simcere Pharmaceutical Group (2096.HK), announced that the U.S. Food and Drug Administration (FDA) has recently cleared the company's Investigational New Drug (IND) application for its independently developed antibody-drug conjugate (ADC), SIM0609, a CDH17-targeting antibody-drug conjugate (ADC) for the treatment of advanced solid tumors.
SIM0609 is a novel ADC candidate targeting cadherin-17 (CDH17). It consists of a humanized monoclonal antibody conjugated with Simcere Zaiming’s proprietary novel topoisomerase I (TOP-I) inhibitor through the company’s proprietary water-soluble cleavable linker. CDH17 is highly expressed in various cancers, including gastric, colorectal, and pancreatic cancers, demonstrating potential as a therapeutic target for advanced solid tumors, particularly gastrointestinal malignancies. SIM0609 had also received IND approval in China on September 8, 2025.